Kornimate/medical-research-clean huggingface dataset:
multicenter, uncontrolled pilot study evaluating the efficacy of eculizumab in the treatment of gemcitabine-induced thrombotic microangiopathies

Conditions: Thrombotic Microangiopathies

Summary: the main objective of this prospective multisite trial is to study the evolution of tma (thrombotic microangiopathy) induced by gemcitabin and treated by eculizumab.


Eligibility criteria:
inclusion criteria: * 1. age ≥ 18 years old 2. previous treatment with gemcitabine within the last 18 months (duration of treatment ≥ 3 consecutive months and cumulative dose should be ≥ 10 grams). 3. neoplasia in remission or not in remission but with an estimated life expectancy \> 6 months 4. acute renal failure defined by 1 of the following 2 criteria : creatinine \> 2 times baseline creatinine and/or diuresis \< 0.5 ml/kg/h for 12 hours. 5. clinical and biological criteria for thrombotic microangiopathy: mechanical hemolytic anemia and/or tthrombocytopeniapatient affiliated with a social security system, 6. adult patient or representative of the adult patient who has read and understood the information letter and signed the consent form. 7. woman of childbearing age with effective contraception as defined by the who (estrogen-progestin or intrauterine device or tubal ligation) for more than one month and a negative -hcg pregnancy test at baseline, for the duration of the study and for at least 5 months after the end of the treatment, or postmenopausal woman (non-medically induced amenorrhea for at least 12 months prior to the baseline visit) or for men, use of protection during sexual intercourse for the duration of the study and for at least 60 days after the end of study treatment exclusion criteria: * 1. progressive neoplasia with a life expectancy of \<6 months 2. patient with a contraindication to the administration of the treatment experienced: soliris® 300 mg concentrate for solution for infusion 3. contraindication to antibiotic prophylaxis 4. thrombotic microangiopathy associated with cancer (metastatic adenocarcinoma with bone marrow invasion, erythromyelemia, disseminated intravascular coagulation) 5. active systemic bacterial infection, untreated or confirmed sepsis (positive blood cultures within 7 days of patient inclusion and not treated with effective antibiotic therapy) 6. unresolved meningococcal infection 7. patient not vaccinated against meningococcal infection 8. pregnant or breastfeeding woman or proven lack of contraception 9. known systemic lupus erythematosus 10. person deprived of liberty by an administrative or judicial decision or person placed under judicial protection, under guardianship or curatorship 11. patient participating in another interventional clinical trial / having participated in another interventional clinical trial within 1 month

Keywords: eculizumab gemcitabine
perioperative goal directed therapy in kidney transplantation

Conditions: Kidney Transplant; Complications

Summary: in literature there is a huge amount of works demonstrating the direct correlation between volemic overload or fluid deficit and hypoperfusion and the increase in the rate of major postoperative complications in patients with high cardiovascular risk and chronic renal failure candidate to kidney transplantation from cadaver. it is also widely demonstrated that in certain populations with high surgical and post-operative complications risk, the adoption of targeted haemodynamic and clinical-therapeutic management protocols is indicated. the current trend is therefore to guarantee greater precision in the intraoperative management of patients undergoing kidney transplantation from cadaver by using a specific protocol that can be framed in the recent and innovative concept of perioperative gold directed therapy (pgdt), resulting from the adoption of an advanced minimally invasive hemodynamic monitoring technology with a special sensor called flotrac (edwards lifesciences), already extensively tested in an extensive case series of high perioperative risk patients underwent to major abdominal surgery, major vascular surgery, major orthopedic surgery and cardio-thoracic surgery. in the present study there will be enrolled all patients who are candidates for kidney transplant from cadaver at the university hospital "g. rodolico" of catania that meet the inclusion criteria of the study and will give their informed consent to participation. the enrolled patients will be monitored for a maximum period of 7 days from transplantation. as control group there will be considered an historical cohort of patients who underwent kidney transplantation from cadaver in 2015, in which a pgdt protocol was not used, but a common hemodynamic monitoring, based on parameters such as central venous pressure and / or invasive arterial pressure, was performed according to the international guidelines.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) classification iii-iv; * age between 18 and 65 years; * first kidney transplantation from cadaver; * absence of atrial fibrillation or severe arrhythmia; * informed consent. exclusion criteria: * lack of informed consent; * age less that 18 or greater than 65 years; * atrial fibrillation and high frequency tachyarrhythmias; * previous transplantation from cadaver.

Keywords: perioperative goal directed therapy minimally invasive hemodynamic monitoring kidney transplantation
blood biomarkers to predict the prognosis of a stroke patient undergoing mechanical thrombectomy

Conditions: Acute Ischemic Stroke

Summary: the goal of this observational study is to evaluate the accuracy of a panel of blood biomarkers and clinical variables in predicting the prognosis of stroke patients treated by mechanical thrombectomy, specifically to predict futile recanalization and mortality.

stroke is the leading cause of long-term disability and the second most common cause of death worldwide, accounting for around 6.7 million deaths each year. the burden of stroke due to illness, disability and early death is set to double within the next 15 years due to an ageing population. the socio-economical cost of the stroke is very high, being around 45 million euros per year in europe. although mechanical thrombectomy is the most effective treatment for stroke patients with large vessel occlusions still a large percentage of patients, around 50%, do not recover despite a successful recanalization (the so called "futile recanalization"). therefore, to anticipate the prognosis of patients treated with mechanical thrombectomy would be clinically relevant and very informative. this observational study evaluates the precision of a rapid test of blood biomarkers in the prognosis of stroke patients treated by mechanical thrombectomy. for that, the investigators will recruit a cohort of 400 consecutive patients treated by thrombectomy. using a multiplex poc for the biomarker measurement and an app in combination with clinical data, the potential of biomarkers to predict the prognosis of a patient will be determined.

Eligibility criteria:
inclusion criteria: * patients \> 18 years old. * patient in whom a mechanical thrombectomy is performed. exclusion criteria: * impossibility of getting a blood sample. * impossibility of performing the test (invalid results) * refusal to provide the informed consent by the patient/relative.

Keywords: large vessel occlusion biomarkers test thrombectomy
slovenian national covid-19 prevalence study

Conditions: COVID-19; SARS-CoV-2

Summary: the investigators are conducting a national covid-19 prevalence survey on a sample of 3,000 inhabitants that were randomly selected from the slovenian population. the sample is representative in age, gender, and geographical distribution. the main objective is to assess how many people in slovenia have covid-19 in april/may 2020 and how many were infected with sars-cov-2 previously. the investigators are using a direct detection of sars-cov-2 rna in nasopharyngeal samples with validated two-target pcr-based commercial assay. for a serological response to the etiological agent, igg and iga anti-sars-cov-2 antibodies are measured in plasma samples using a validated commercial assay.

the investigators are conducting a national covid-19 prevalence survey on a sample of 3,000 inhabitants that we have randomly selected from the slovenian population. the sample is representative in age, gender, and geographical distribution. the main objective is to assess how many people in slovenia have covid-19 in april/may 2020 and how many were infected with sars-cov-2 previously. direct detection of sars-cov-2 rna in nasopharyngeal samples is performed with validated two-target pcr-based commercial assay. for a serological response to the etiological agent, igg and iga anti-sars-cov-2 antibodies are measured in plasma samples using a validated commercial assay. principal aims of the study are to systematically and accurately assess: * how many people in slovenia are actively infected with sars cov-2 in april/may 2020? * how many are asymptomatic and do not even know they are or were infected? * how many people in slovenia have contacted sars-cov-2 and already have covid-19 until mid may 2020? the study is carried out by the institute of microbiology and immunology of university of ljubljana. the institute is slovenia's leading institution for microbiology and immunology research. the study is joined by a team of it specialists, data scientists, and statisticians from the other departments of the university of ljubljana. to speed-up and support the study, an innovative information infrastructure for data gathering and management was purposely developed and optimized for the study. the system fosters error-free data collection, automatic processing of questionnaires using artificial intelligence approaches, and provides security for sensitive clinical data. all participants will be passively followed up twice monthly and tested again for the presence of anti-sars-cov-2 antibodies in plasma samples six months after enrollment.

Eligibility criteria:
inclusion criteria: signed informed consent only. exclusion criteria: declined participation, no response on study invitation, no samples collected.
efficacy study of sequential therapy of peginterferon alfa-2a following entecavir in patient with chronic hepatitis b.

Conditions: Hepatitis B, Chronic

Summary: evaluate the safety and efficacy of peginterferon alfa-2a following entecavir compared with peginterferon alfa-2a monotherapy in patient with hbeag positive chronic hepatitis b. * increased hbeag seroconversion rate * increased hbsag loss rate * to define the best treatment condition for chronic hbv hepatitis patients


Eligibility criteria:
inclusion criteria: * chronic hepatitis b patients with hbeag positive, hbsag positive, hbv dna \> 100,000 copies/ml and anti-hbs negative, serum alt exceeding 2 x uln but less than 10 x uln. exclusion criteria: * patient infected concurrently with hcv, hdv and hiv or patient with a history of antiviral treatment for hepatitis b or patient with hepatic decompensation.
circulating melanoma cells in metastatic patients treated with selective braf inhibitors

Conditions: Metastatic Melanoma

Summary: the purpose of this study, is to evaluate circulating melanoma cell (cmc) changes in metastatic melanoma (mm) patients, undergoing treatment with selective inhibitors of mutated braf.

this is an observational prospective pilot study aimed to investigate the association between changes of total and apoptotic cmc count and disease progression in mm patients undergoing treatment with selective inhibitors of mutated b-raf.

Eligibility criteria:
inclusion criteria: * fourth stage melanoma patients with both measurable and not measurable lesions undergoing treatment with selective b-raf inhibitors will be included. to determine the prevalence of cmc-positive patients in iv stage melanoma, patients without mutated b-raf undergoing chemotherapy and/or vaccines will be also enrolled at baseline, as part of study protocols approved and activated in the participating centers. * informed written consent. exclusion criteria: * inadequate compliance to multiple blood draws (baseline, 15 days, 1th month, 4th month, and/or at progression) as scheduled in this adjunctive biologic study for patients carrying b-faf mutation; inadequate compliance to adjunctive blood draws, as scheduled at baseline for braf wild-type * previously exposure to immunological treatment.

Keywords: circulating melanoma cells in metastatic melanoma
bioavailability, pharmacokinetic and mechanistic study of sinetrol® xpur, a polyphenol-rich ingredient

Conditions: Overweight

Summary: the purpose of the study is to investigate the metabolization and the bioavailability of bioactive compounds from sinetrol® xpur, a polyphenol-rich ingredient, during a 16-week long chronical supplementation. it will be investigated the mechanism of action in adipocyte cells to try to explain the beneficial effects of the ingredient on body composition, especially on both abdominal subcutaneous and visceral fat mass.


Eligibility criteria:
inclusion criteria: 1. provision of signed and dated informed consent form 2. stated willingness to comply with all study procedures and availability for the duration of the study 3. male and female with 30% min. and 70% max. of each sex, aged range: 20-50 years old 4. overweight bmi range (27-30) 5. having a total fat mass (bia assessment) ≥ 25% for men and ≥ 32% for women 6. in good general health as evidenced by medical history 7. ability to take oral medication and be willing to adhere to the regimen 8. agreement to adhere to lifestyle considerations (see section 5.3) throughout study duration exclusion criteria: 1. metabolic/chronic disorders or any kind of disease 2. current use of any medication or food supplement 3. have in the past been in long-term antibiotherapy (1 month or more) and/or a regular antiobiotherapy in the past 12 months 4. former obese with a history of yoyo-effect 5. have been involved in a weight loss program in the past 12 months or subjected to a weight reduction surgery 6. pregnancy or lactation, or women wanting to have a baby 7. menopausal women 8. known allergic reactions to components of the supplement, i.e., orange, grapefruit, guarana and/or caffeine 9. having started or quit smoking 10. having a high alcohol consumption
a study to evaluate the efficacy and safety of obinutuzumab in participants with systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus

Summary: this parallel-group, double-blind, placebo-controlled study will evaluate the efficacy and safety of obinutuzumab versus placebo in participants with active, autoantibody-positive systemic lupus erythematosus (sle) who are treated with standard-of-care therapy.


Eligibility criteria:
inclusion criteria: * diagnosis of sle according to the 2019 european league against rheumatism/american college of rheumatology (eular/acr) classification criteria \>=12 weeks prior to screening * anti-nuclear antibody (ana) \>=1:80, or anti-dsdna and/or anti-sm antibodies above the upper limit of normal (uln), as determined by the central laboratory at screening * low c3 or low c4 or low ch50 complement as determined by the central laboratory at screening * high disease activity at screening, based on; bilag-2004 (category a disease in \>=1 organ system and/or category b disease in \>=2 organ systems), systemic lupus erythematosus disease activity index 2000 (sledai-2k) (score \>=8) and physician's global assessment (pga) (score \>=1.0 on a 0 to 3 visual analogue scale \[vas\]) * high disease activity on day 1, based on; sledai-2k (score \>=8) and pga (score \>=1.0 on a 0 to 3 vas) * current receipt of \>=1 of the following classes of standard therapies for the treatment of sle at stable doses: oral corticosteroid (ocs), antimalarials, conventional immunosuppressants * other inclusion criteria may apply * the medical monitor may be consulted if there are any questions related to eligibility criteria exclusion criteria: * pregnancy or breastfeeding * presence of significant lupus-associated renal disease and/or renal impairment * receipt of an excluded therapy, including any anti-cd20, anti-cd19 therapy less than 9 months prior to screening or during screening; or cyclophosphamide, tacrolimus, ciclosporin, or voclosporin during the 2 months prior to screening or during screening * significant or uncontrolled medical disease which, in the investigator's opinion, would preclude patient participation * known active infection of any kind or recent major episode of infection * intolerance or contraindication to study therapies * other exclusion criteria may apply
reactivation of varicella zoster virus and risk of vascular disease

Conditions: Varicella Zoster; Stroke; Transient Ischaemic Attack; Acute Myocardial Infarction

Summary: the purpose of this study is to investigate whether there is an association between stroke or heart attack and reactivation of varicella zoster virus, measured by antibody levels, using linked data from the health survey for england and secondary care.

this study will use a case control design to investigate whether adult participants in the health survey for england between 2009 and 2013 who were admitted to hospital with either a stroke or heart attack had higher preceding levels of varicella zoster virus antibodies measured in stored serum samples compared to matched controls with no history of heart attack or stroke, controlling for a range of potential demographic, lifestyle and clinical confounders. this study is funded by the university college london hospitals biomedical research centre fast track grant scheme and has received ethics approval (ref 15/nw/0456).

Eligibility criteria:
inclusion criteria: * previous participant in the hse between 2009 and 2013 with stored serum available. * either a record of stroke or tia or mi in linked hes data between 01/01/2009 and 31/12/2013 or selected as a matched control for those with a record of stroke/ tia/mi in hes data. * male or female, aged 16 years or above. exclusion criteria: * hse participant with no stored serum sample
sleep management and recovery after traumatic brain injury in kids: pilot intervention of melatonin

Conditions: Traumatic Brain Injury; Critical Illness; Sleep

Summary: sleep wake disturbances compound recovery in over half of pediatric traumatic brain injury survivors, leading to impaired quality of life, and few effective interventions exist to treat this important morbidity. therefore, this study will conduct a randomized controlled trial evaluating a melatonin intervention started during hospitalization and continued after discharge compared to placebo. the trial will investigate if this intervention is feasible, acceptable, and effective at reducing sleep wake disturbances as measured on the sleep disturbances scale for children 1-month after hospital discharge. participants will be randomly assigned to receive the intervention (melatonin) or to the control group (placebo) with a goal of equal numbers of participants in each group and all will receive sleep education. participants will be followed closely after consent and outcomes will be assessed at hospital discharge, and 1-month. outcomes will focus on feasibility (ability to recruit patients into the trial) and acceptability (patient safety and satisfaction), but will also assess the effectiveness of the intervention to reduce sleep disturbances after discharge. the investigators will assess sleep using questionnaires and actigraphy (watch-like activity monitors). exploratory outcomes will include global health outcomes.


Eligibility criteria:
inclusion: * children age ≥6 years and \<19 years * traumatic brain injury defined as disruption of the normal function of the brain resulting from blunt force injury with a severity defined as mild complicated, moderate, or severe by the glasgow coma scale with the presence of intracranial injury on imaging * admission to oregon health \& science university hospitals * deemed likely to survive hospitalization by clinical care team * able to tolerate enteral medications within 72 hours of admission * child participant resides with parent or legal guardian exclusion: * lack stable means of communication with study team (phone, email, mailing address) * abusive trauma suspected or confirmed * dialysis * extracorporeal support (e.g. ecmo) * significant liver injury defined as \>2x normal levels for ast or alt * clinical team safety concerns with use of intervention * pregnancy * prisoners

Keywords: pediatric traumatic brain injury melatonin sleep intervention
first-line folfoxiri in combination with bevacizumab for metastatic colorectal cancer

Conditions: Colorectal Cancer Metastatic

Summary: this is a single-arm, open-label, multicentre phase ii study evaluating the safety and efficacy of the combination of the g.o.n.o. folfoxiri regimen with bevacizumab as first-line treatment of metastatic colorectal cancer.


Eligibility criteria:
inclusion criteria: * histologically confirmed colorectal adenocarcinoma * unresectable and measurable metastatic disease (recist criteria) * male or female, aged \> 18 years and ≤ 75 years * ecog performance status (ps) \< 2 if aged \< 71 years * ecog ps = 0 if aged 71-75 years * life expectancy of more than 3 months * adequate haematological function: anc ≥ 1.5 x 109/l; platelets ≥ 100 x 109/l, hb ≥ 9 g/dl * inr ≤ 1.5 and aptt ≤ 1.5 x uln within 7 days prior to starting study treatment * adequate liver function: serum bilirubin ≤ 1.5 x uln; alkaline phosphatase and transaminases ≤ 2.5 x uln (in case of liver metastases \< 5 x uln) * serum creatinine ≤ 1.5 x uln * urine dipstick for proteinuria \< 2+. if urine dipstick is ≥ 2+, 24- hour urine must demonstrate ≤ 1 g of protein in 24 hours * previous adjuvant chemotherapy is allowed if more than 12 months have elapsed between the end of adjuvant therapy and first relapse * at least 6 weeks from prior radiotherapy and 4 weeks from surgery exclusion criteria: * prior palliative chemotherapy * prior treatment with bevacizumab * bowel obstruction (or subobstruction) * history of inflammatory enteropathy or extensive intestinal resection (\> hemicolectomy or extensive small intestine resection with chronic diarrhea) * symptomatic peripheral neuropathy \> 2 grade ncic-ctg criteria * presence or history of cns metastasis * active uncontrolled infections * active disseminated intravascular coagulation * major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to treatment, or anticipation of the need for major surgery during the course of the study * central venous access device (cvad) for chemotherapy administration inserted within 2 days prior to study treatment start * past or current history of malignancies other than colorectal carcinoma, except for curatively treated basal and squamous cell carcinoma of the skin cancer or in situ carcinoma of the cervix * clinically significant cardiovascular disease, for example cerebrovascular accidents (cva) (≤ 6 months before treatment start), myocardial infarction (≤ 6 months before treatment start), unstable angina, nyha ≥ grade 2 chronic heart failure (chf), uncontrolled arrhythmia * uncontrolled hypertension * 24-hour urine protein \> 1 g if dipstick \> 2+ * history of thromboembolic or hemorrhagic events within 6 months prior to treatment * evidence of bleeding diathesis or coagulopathy * serious, non healing wound/ulcer or serious bone fracture * no therapeutic anticoagulation or antiplatelet agents or nsaid with anti-platelet activity (aspirin ≤ 325 mg/day allowed) * pregnancy or lactation * fertile women (\< 2 years after last menstruation) and men of childbearing potential not willing to use effective means of contraception